BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTECTA XT DR

    MDR report key: 2954490 · Received February 11, 2013

    Report

    Report Number
    3004209178-2013-02417
    Event Type
    Injury
    Date Received
    February 11, 2013
    Date of Event
    December 13, 2012
    Report Date
    December 27, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LWS
    PMA / PMN Number
    P980016/S211
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT PRODUCT: 6947 IMPLANTABLE TACHY LEAD (B)(6) 2008. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER THE ROUTINE CHANGE OUT OF THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) THE IMPEDANCES ON THE RIGHT VENTRICULAR LEAD WERE HIGH AND TRIGGERED AN ALERT. IT WAS DISCOVERED THE LEADS WERE NOT PLACED IN THE HEADER CORRECTLY. THE LEADS WERE RE-INSERTED INTO THE DEVICE AND REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58554 PROTECTA XT DR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC MED REL MEDTRONIC PUERTO RICO D314DRG

    Patients

    Seq Age Sex Outcome Treatment
    1 00060 YR Hospitalization| R 4076 IMPLANTABLE PACING LEADS